HeartX Viewer

Organization name

GETEMED Medizin- und Informationstechnik AG

SRN

DE-MF-000012384

Manufacturer status

Active

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• CW999

  The HeartX Viewer is not a monitoring system for emergency situations and is not suitable for patients whose clinical condition requires continuous monitoring of physiological vital signs.

Primary placement in Germany; available across 10 countries total.

Trade name

HeartX Viewer

UDI-DI code

04250903202483

Basic UDI-DI

0425090320241N4

Reference / catalog number

79313011

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The HeartX Viewer is a software that runs in an electronic health record system. It is intended to display ECG data from a compatible ECG device (GETEMED - PhysioMem PM 100) via a compatible receiving system (GETEMED ReSTA). The user is able to interprete visualised ECG data by using the measurement of ECG data and to make a diagnosis. The presentation of ECG data concerning zoom and amplitude can be set by the user. The HeartX Viewer is indicated for the diagnostic evaluation of adult and pediatric patients with asymptomatic and symptomatic disturbances of the cardiac rhythm and for the evaluation of recurrent unexplained episodes of racing heart, syncope, palpitations or dizziness.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12050492HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE

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